Influence of blinding on treatment effect size estimate in randomized controlled trials of oral health interventions

BMC Medical Research Methodology
Humam SaltajiCarlos Flores-Mir

Abstract

Recent methodologic evidence suggests that lack of blinding in randomized trials can result in under- or overestimation of the treatment effect size. The objective of this study is to quantify the extent of bias associated with blinding in randomized controlled trials of oral health interventions. We selected all oral health meta-analyses that included a minimum of five randomized controlled trials. We extracted data, in duplicate, related to nine blinding-related criteria, namely: patient blinding, assessor blinding, care-provider blinding, investigator blinding, statistician blinding, blinding of both patients and assessors, study described as "double blind", blinding of patients, assessors, and care providers concurrently, and the appropriateness of blinding. We quantified the impact of bias associated with blinding on the magnitude of effect size using a two-level meta-meta-analytic approach with a random effects model to allow for intra- and inter-meta-analysis heterogeneity. We identified 540 randomized controlled trials, included in 64 meta-analyses, analyzing data from 137,957 patients. We identified significantly larger treatment effect size estimates in trials that had inadequate patient blinding (difference in treatm...Continue Reading

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Citations

Jan 8, 2019·The Journal of Maternal-fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·Masoumeh MirzamoradiMahmood Bakhtiyari
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